AbbVie Receives U.S. FDA Approval of VIEKIRA PAK™ (Ombitasvir/Paritaprevir/Ritonavir Tablets; Dasabuvir Tablets) for the Treatment of Chronic Genotype 1 Hepatitis C

- In Phase 3 clinical trials, VIEKIRA PAK cured 95-100 percent of hepatitis C patients, with less than 2 percent of patients experiencing virological failure

- Tolerability profile shows more than 98 percent of patients completed a full course of therapy

- All-oral interferon-free regimen also approved for HCV/HIV-1 co-infection and patients who have undergone a liver transplant

NORTH CHICAGO, Illinois, Dec. 19, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved AbbVie's (NYSE:ABBV) VIEKIRA PAK™, an all-oral, interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis. VIEKIRA PAK is the only FDA-approved regimen that contains three distinct mechanisms of action - NS5A inhibitor, NS3/4A protease inhibitor and a non-nucleoside NS5B polymerase inhibitor - that work together to attack the virus at three separate stages of the disease lifecycle to inhibit it from reproducing.

"We are proud of the work of our research and development organization to bring this important therapy, offering high cure rates, to patients with hepatitis C. We believe appropriate patients, regardless of their fibrosis stage, should have broad market access to VIEKIRA PAK, and we are committed to supporting access to this therapy," said Richard Gonzalez, Chairman of the Board and Chief Executive Officer, AbbVie. "This is the first of several potential new therapies that we are advancing to treat a multitude of serious disease states, and we anticipate bringing them to market in the coming years."

The approval of VIEKIRA PAK is supported by a robust clinical development program designed to study the safety and efficacy of the regimen in more than 2,300 enrolled patients across 25 countries. The program consisted of six pivotal Phase 3 studies, which demonstrated that VIEKIRA PAK cured 95-100 percent of GT1a and GT1b hepatitis C patients, including patients new and experienced to treatment, and patients with compensated cirrhosis, with less than 2 percent of patients experiencing virological failure. Additionally, more than 98 percent of patients in clinical trials completed a full course of therapy.